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Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model KP-7500

by K-jump Health Co., Ltd.

510(k) K083753

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK083753 Date19 Jun 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model Kp-7500, Fully Fuzzy Auto Digital Upper Arm Blood Pressu
510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model KP-7500, is a fully automatic digital device designed for measuring blood pressure in the upper arm. It utilises fuzzy logic technology to enhance accuracy and reliability in systolic and diastolic readings, making it suitable for clinical and home use.

This device is intended for single-use or reusable applications in cardiovascular monitoring settings, as classified under product code DXN. It has received FDA 510(k) clearance as substantially equivalent, with no third-party certification noted. The monitor is supplied as a Class II device and requires adherence to regulatory standards for blood pressure measurement devices.

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